Expired Study
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Boston, Massachusetts 02114


Purpose:

RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for malignant glioma. PURPOSE: Phase I/II trial to study the effectiveness of immunotoxin therapy in treating patients who have malignant glioma.


Study summary:

OBJECTIVES: - Determine the toxic effects and maximum tolerated dose (MTD) of interstitial interleukin-13 PE38QQR immunotoxin in patients with malignant glioma. - Determine the response rate, duration of response, time to response, overall survival, and time to progression in patients treated with this regimen. - Determine the toxic effects of this drug at the MTD in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients undergo stereotactic biopsy of brain tumor followed by CT guided stereotactic placement of 2 intratumoral catheters on day 0. Patients with histologically confirmed malignant glioma receive interleukin-13 PE38QQR immunotoxin interstitially over 96 hours beginning on day 1. Patients with a residual enhancing mass undergo repeat catheter placement on day 56 and then receive a second interstitial infusion beginning on day 57 in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of interleukin-13 PE38QQR immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for phase I of the study within 6 months and a total of 12-35 patients will be accrued for phase II of the study within 10-12 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven malignant glioma (grade 3 or 4) - Anaplastic astrocytoma - Glioblastoma multiforme - Malignant mixed oligoastrocytoma - Must have undergone cranial radiotherapy with tumor dose of at least 48 Gy and at least 12 weeks prior to study - Must have undergone supratentorial brain tumor surgery or biopsy - Must have radiographic evidence of recurrent or progressive supratentorial tumor compared with prior study - Must have solid portion measuring 1.0-5.0 cm in maximum diameter - Maximum of 1 satellite lesion allowed if separated from the primary mass by less than 3 cm - No tumor crossing the midline - No leptomeningeal tumor dissemination - No impending herniation or spinal cord compression - No uncontrolled seizures PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Hemoglobin at least 10 g/dL - Platelet count at least 100,000/mm^3 Hepatic: - PT and PTT no greater than upper limit of normal (ULN) - SGOT and SGPT no greater than 2.5 times ULN - Bilirubin no greater than 2.0 mg/dL Renal: - Not specified Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior intralesional chemotherapy for malignant glioma - At least 3 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas) and recovered - No concurrent chemotherapy Endocrine therapy: - Concurrent corticosteroids allowed, but dose must remain stable or be tapered during study Radiotherapy: - See Disease Characteristics - No prior focal radiotherapy (e.g., any form of stereotactic radiotherapy or brachytherapy) for malignant glioma Surgery: - See Disease Characteristics Other: - Recovered from any prior therapy - No other concurrent investigational agent


NCT ID:

NCT00006268


Primary Contact:

Study Chair
Jon Weingart, MD
Sidney Kimmel Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02114
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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